Amneal Secures FDA Approval For Generic RESTASIS® Cyclosporine Eye Drop In Single-Use Vials

Amneal Pharmaceuticals announced that the U.S. FDA has approved its cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free generic version of Allergan’s RESTASIS®. The product will be supplied in single-use vials and is the latest addition to Amneal’s expanding portfolio of complex ophthalmic generics.

The therapy is an immunomodulatory eye drop designed to increase tear production in patients whose lacrimal function is reduced due to inflammation associated with dry eye disease. Clinical studies have shown that this improvement is not observed in patients already using topical anti-inflammatory treatments or punctal plugs. The most commonly reported side effect is ocular burning.

“Dry eye disease affects millions of adults in the United States and can significantly impact their quality of life,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “We are proud to bring another difficult-to-manufacture ophthalmic product to market, reinforcing Amneal’s strong execution in complex formulations and our expanding leadership in ophthalmology within the Affordable Medicines segment. Cyclosporine joins a series of recent approvals across inhalation, injectable, and ophthalmic categories, underscoring Amneal’s strong execution in high-quality sterile manufacturing.”

RESTASIS and its generic counterparts represent a major category within ophthalmology, with IQVIA reporting approximately $2.0 billion in U.S. annual sales for preservative-free cyclosporine 0.05% vials for the 12 months ending September 2025. Amneal’s entry into this space is expected to enhance access to an established dry eye therapy.

Amneal, headquartered in Bridgewater, New Jersey, continues to broaden its footprint in the generic, specialty, and federal distribution markets. The company’s portfolio spans more than 290 pharmaceuticals across its Affordable Medicines, Specialty, and AvKARE business segments, covering therapeutic areas from central nervous system disorders to endocrinology and complex injectables.